Pharmacovigilance
A named qualified person for pharmacovigilance, adverse event reporting to the Pharmacy and Poisons Board, periodic safety reports and safety signal management.
Regulatory Affairs
Product registration with the Pharmacy and Poisons Board and other East African regulators, dossiers, variations, renewals and local representation.
Quality & Compliance
Pharmacovigilance audits, inspection readiness and written procedures that reflect how your team really works.
Medical Information
A medical information service that answers questions about your products and captures adverse events.
- Medical information service
- Adverse event intake
Training
Pharmacovigilance and regulatory affairs training for your staff, online or at your premises.
- Pharmacovigilance training
- Regulatory affairs training
Market Access & Advisory
Advice on entering the Kenyan and East African markets and keeping up with regulatory changes.
- Market entry advice
- Regulatory updates and intelligence
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Who we help
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Services

Decisions based on current rules

Market entry strategy and regulatory intelligence for East Africa.

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Market Access & Advisory

What’s included

Market entry advice

Which markets, in which order, with which documents: a plan before you spend.

Regulatory updates and intelligence

Monitoring of regulator guidance and changes that affect your products.

What you receive

A market entry plan with documents and sequence
A regulatory intelligence briefing

How it runs

Market Access & Advisory FAQ

Kenya, Uganda, Tanzania, Rwanda and Ethiopia, with Burundi and South Sudan on request.

Decisions based on current rules

Book a regulatory strategy session